Clinical Chemistry

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CodeDevice nameClass21 CFR510(k) (3y)
JHHElectrophoretic Method, Lecithin/Sphingomyelin RatioClass 221 CFR 862.1455
JHIVisual, Pregnancy Hcg, Prescription UseClass 221 CFR 862.1155375
JHJAgglutination Method, Human Chorionic GonadotropinClass 221 CFR 862.115596
JHLMicrodensitometry Method, LipoproteinsClass 121 CFR 862.14751
JHMColorimetric Method, LipoproteinsClass 121 CFR 862.14759
JHNTurbidimetric Method, LipoproteinsClass 121 CFR 862.14757
JHOElectrophoretic Separation, LipoproteinsClass 121 CFR 862.147526
JHPRadial Immunodiffusion, LipoproteinsClass 121 CFR 862.1475
JHQNephelometric Method, LipoproteinsClass 121 CFR 862.14751
JHSDifferential Rate Kinetic Method, Cpk Or IsoenzymesClass 221 CFR 862.121538
JHTChromatographic Separation, Cpk IsoenzymesClass 221 CFR 862.121521
JHWU.V. Method, Cpk IsoenzymesClass 221 CFR 862.121527
JHXFluorometric Method, Cpk Or IsoenzymesClass 221 CFR 862.121548
JHYColorimetric Method, Cpk Or IsoenzymesClass 221 CFR 862.121540
JIAEnzymatic Methods, GalactoseClass 121 CFR 862.13109
JIBU.V. Method, GalactoseClass 121 CFR 862.1310
JICColorimetric Method, GalactoseClass 121 CFR 862.1310
JIDPhotometric Method, AmmoniaClass 121 CFR 862.10653
JIEMethod, Ion-Exchange, AmmoniaClass 121 CFR 862.1065
JIFEnzymatic Method, AmmoniaClass 121 CFR 862.106530
JIGElectrode, Ion-Specific Method, AmmoniaClass 121 CFR 862.1065
JIJWet Ash Method, Protein-Bound IodineClass 121 CFR 862.1640
JIKDry Ash Method, Protein-Bound IodineClass 121 CFR 862.1640
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Class 221 CFR 862.134081
JIMMethod, Metallic Reduction, Glucose (Urinary, Non-Quantitative)Class 221 CFR 862.13402
JINNitroprusside, Ketones (Urinary, Non-Quant.)Class 121 CFR 862.143524
JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)Class 121 CFR 862.164513
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Class 121 CFR 862.164538
JISCalibrator, PrimaryClass 221 CFR 862.1150130
JITCalibrator, SecondaryClass 221 CFR 862.1150245
JIWCalibrator, SurrogateClass 221 CFR 862.115017
JIXCalibrator, Multi-Analyte MixtureClass 221 CFR 862.1150302
JIYPhotometric Method, Iron (Non-Heme)Class 121 CFR 862.141067
JIZAtomic Absorption, Iron (Non-Heme)Class 121 CFR 862.1410
JJARadio-Labeled Iron Method, Iron (Non-Heme)Class 121 CFR 862.14104
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-QuantClass 121 CFR 862.11155
JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical UsClass 121 CFR 862.215032
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClass 121 CFR 862.2160208
JJFAnalyzer, Chemistry, Micro, For Clinical UseClass 121 CFR 862.217057
JJGAnalyzer, Chemistry, Centrifugal, For Clinical UseClass 121 CFR 862.214030
JJHClinical Sample ConcentratorClass 121 CFR 862.231015
JJIAnalyzer, Enzyme, For Clinical UseClass 121 CFR 862.25008
JJJCounter (Beta, Gamma) For Clinical UseClass 121 CFR 862.232063
JJKOncometer, Plasma, For Clinical UseClass 121 CFR 862.27204
JJLPlasma Viscometer For Clinical UseClass 121 CFR 862.29201
JJMOsmometer For Clinical UseClass 121 CFR 862.273012
JJNApparatus, Electrophoresis, For Clinical UseClass 121 CFR 862.248534
JJOFlame Emission Photometer For Clinical UseClass 121 CFR 862.254022
JJPElectrode, Ion Selective (Non-Specified)Class 121 CFR 862.20503
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClass 121 CFR 862.2300258
JJRElectrolyte Controls (Assayed And Unassayed)Class 121 CFR 862.166017
JJSControls For Blood-Gases, (Assayed And Unassayed)Class 121 CFR 862.166067
JJTEnzyme Controls (Assayed And Unassayed)Class 121 CFR 862.166097
JJWUrinalysis Controls (Assayed And Unassayed)Class 121 CFR 862.166061
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Class 121 CFR 862.1660493
JJYMulti-Analyte Controls, All Kinds (Assayed)Class 121 CFR 862.1660673
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClass 221 CFR 862.1675236
JKBRadioimmunoassay, Compound S (11-Deoxycortisol)Class 121 CFR 862.11851
JKCRadioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)Class 121 CFR 862.124528
JKDRadioimmunoassay, C-Peptides Of ProinsulinClass 121 CFR 862.113510
JKFDinitrophenyl Hydrazone Measurement (Colorimetric), Hydroxybutyric DehClass 121 CFR 862.13802
JKGL-Isocitrate And Nadp (U.V.), Isocitric DehydrogenaseClass 121 CFR 862.14201
JKHHydrazone Deriv. Of Alpha-Ketogluterate (Colorimetry), Isocitric DehydClass 121 CFR 862.14201
JKJFluorometric Measurement, PorphyrinsClass 121 CFR 862.15953
JKLAcid, Delta-Aminolevulinic, Ion-Exchange Columns With ColorimetryClass 121 CFR 862.10602
JKPChromium-51, Blood VolumeClass 121 CFR 862.11301
JKRRadioimmunoassay, CalcitoninClass 221 CFR 862.114020
JKWN-Acetyl-L-Tyrosine Ethyl Ester (U.V.), ChymotrypsinClass 121 CFR 862.1180
JKXN-Benzoyl-L-Tyrosine Ethyl Ester (U.V.), ChymotrypsinClass 121 CFR 862.1180
JKYOxalydihydrazide (Spectroscopic), CopperClass 121 CFR 862.1190
JKZDiethyldithiocarbamate (Colorimetric), CopperClass 121 CFR 862.1190
JLAConversion To Creatinine, CreatineClass 121 CFR 862.12102
JLBAtp And Creatine Kinase (Enzymatic), CreatineClass 121 CFR 862.12103
JLCNitroprusside Reaction (Qualitative, Urine), CystineClass 121 CFR 862.12402
JLDChromatographic, CystineClass 121 CFR 862.1240
JLERadioimmunoassay, DesoxycorticosteroneClass 121 CFR 862.1250
JLFRadioimmunoassay, EtiocholanoloneClass 121 CFR 862.1285
JLGConversion To Ferric Hydroxymates (Colorimetric), Fatty AcidsClass 121 CFR 862.12902
JLHTitrimetric, Fatty AcidsClass 121 CFR 862.12901
JLITetrahydrofolate, Enzymatic (U.V.), Formiminoglutamic AcidClass 121 CFR 862.1305
JLJUridine-5-Diphosphoglucose, Nad (U.V.), Alpha-D Galactose-1-PhosphateClass 221 CFR 862.13151
JLKSodium Hydroxide And Phenol Red (Titrimetric), Gastric AcidityClass 121 CFR 862.1320
JLLTubeless Analysis, Gastric AcidityClass 121 CFR 862.1320
JLNChromatographic, GlutathioneClass 121 CFR 862.1365
JLOEnzymatic (Glutathione Reductase), GlutathioneClass 121 CFR 862.1365
JLPSpectrophotometric Method, PregnanediolClass 121 CFR 862.16051
JLQSpectrophotometric Method, PregnanetriolClass 121 CFR 862.1610
JLRGas Chromatography, PregnanetriolClass 121 CFR 862.1610
JLSRadioimmunoassay, ProgesteroneClass 121 CFR 862.162057
JLTAcid, Pyruvic, Enzymatic (U.V.)Class 121 CFR 862.1655
JLWRadioimmunoassay, Thyroid-Stimulating HormoneClass 221 CFR 862.1690242
JLXRadioimmunoassay, 17-HydroxyprogesteroneClass 121 CFR 862.139519
JLYPhosphoglycerate Mutase (Colorimetric), 2,3-Diphosphoglyceric AcidClass 121 CFR 862.1255
JLZNadh, Phosphoglycerate Mutase, Atp (U.V.) 2,3-Diphosphoglyceric AcidClass 121 CFR 862.1255
JMAAcid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)Class 121 CFR 862.10953
JMDRadioimmunoassay, Total Estrogens, NonpregnancyClass 121 CFR 862.12752
JMERadioimmunoassay, GlucagonClass 121 CFR 862.13353
JMFRadioimmunoassay, Human Placental LactogenClass 221 CFR 862.158511
JMIChromatographic, HistidineClass 121 CFR 862.1375
JMJMicrobiological, HistidineClass 121 CFR 862.1375
JMKAcid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric DehydrogenaseClass 121 CFR 862.138016
JMMColumn Chromatography & Color Development, HydroxyprolineClass 121 CFR 862.140021
JMNExtraction Plus Chromatography With Color By Ninhydrin, HydroxyprolineClass 121 CFR 862.1400
JMOFerrozine (Colorimetric) Iron Binding CapacityClass 121 CFR 862.141546
JMQM. Lysodeikticus Cells (Spectrophotometric), Lysozyme (Muramidase)Class 121 CFR 862.1490
JMRImmunochemical, Lysozyme (Muramidase)Class 121 CFR 862.1490
JMSAcid, Oxalacetic And Nadh Oxidation (U.V.), Malic DehydrogenaseClass 121 CFR 862.1500
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Class 121 CFR 862.151013
JMW2,4-Dinitrofluorobenzene (Spectroscopic), Nitrogen (Amino-Nitrogen)Class 121 CFR 862.1515
JMXNinhydrin, Nitrogen (Amino-Nitrogen)Class 121 CFR 862.15152
JMYCitrulline, Arsenate, Nessler (Colorimetry), Ornithine Carbamyl TransfClass 121 CFR 862.1535
JMZComparison Of Freezing Points & Stds. Of Known Osmotic Pressure, OsmolClass 121 CFR 862.15402
JNAVapor Pressure, Osmolality Of Serum & UrineClass 121 CFR 862.1540
JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), PhenylalanineClass 221 CFR 862.155515
JNCColumn Or Paper Chromatography Plus Ninhydrin, PhenylalanineClass 221 CFR 862.1555
JNDNadp Reduction, 6-Phosphogluconate DehydrogenaseClass 121 CFR 862.1565
JNEGlucose-6-Phosphate (Colorimetric), Phosphohexose IsomeraseClass 121 CFR 862.1570
JNFIon-Exchange Resin, Ehrlich'S Reagent, PorphobilinogenClass 121 CFR 862.15901
JNGRadioimmunoassay, PregnenoloneClass 121 CFR 862.1615
JNJPhosphoenol Pyruvate, Adp, Nadh, Pyruvate KinaseClass 121 CFR 862.1650
JNKBeta-D-Fructose & Nadh Oxidation (U.V.), Sorbitol DehydrogenaseClass 121 CFR 862.1670
JNNP-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), TrypsinClass 121 CFR 862.1725
JNON-Benzoyl-L-Arginine Ethyl Ester (U.V.), TrypsinClass 121 CFR 862.17257
JNPInfrared Spectroscopy Measurement, Urinary Calculi (Stone)Class 121 CFR 862.1780
JNQQualitative Chemical Reactions, Urinary Calculi (Stone)Class 121 CFR 862.1780
JNSStannous Chloride - Hydrazine, PhospholipidsClass 121 CFR 862.1575
JNTChromatographic, PhospholipidsClass 121 CFR 862.15753
JNXMembrane Osmometry, Plasma OncometryClass 121 CFR 862.1530
JNYGlyceralde-3-Phosphate, Nadh (Enzymatic), Triose Phosphate IsomeraseClass 121 CFR 862.1720
JNZFluorometric, UroporphyrinClass 121 CFR 862.1790
JOAAcid, Trifluoroacetic, Vitamin A, Hexane ExtractionClass 121 CFR 862.1805
JOBHexane Extraction, Fluorescence, Vitamin EClass 121 CFR 862.18151
JOCColorimetric, XyloseClass 121 CFR 862.18201
JPZColorimetric Method, Gamma-Glutamyl TranspeptidaseClass 121 CFR 862.136033
JQAElectrophoretic, Gamma-Glutamyl Transpeptidase IsoenzymesClass 121 CFR 862.1360
JQBKinetic Method, Gamma-Glutamyl TranspeptidaseClass 121 CFR 862.136052
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClass 121 CFR 862.205038
JQDResin, Ion-Exchange, Thioglycolic Acid, Colorimetry, Iron Binding CapaClass 121 CFR 862.1415
JQEResin, Ion-Exchange, Ascorbic Acid, Colorimetry, Iron Binding CapacityClass 121 CFR 862.14156
JQFBathophenanthroline, Iron Binding CapacityClass 121 CFR 862.14158
JQGRadiometric, Fe59, Iron Binding CapacityClass 121 CFR 862.14155
JQHTrinitrobenzene Sulfonate (Spectroscopic), Nitrogen (Amino-Nitrogen)Class 121 CFR 862.1515
JQIRotating Disc, Plasma ViscometryClass 121 CFR 862.1475
JQJDensitometeric, Protein FractionationClass 121 CFR 862.16301
JQKImmunodiffusion, Protein FractionationClass 121 CFR 862.16301
JQLSpectrophotometric, UroporphyrinClass 121 CFR 862.1790
JQMP-Bromoaniline, XyloseClass 121 CFR 862.1820
JQNColorimetric, MucopolysaccharidesClass 121 CFR 862.15052
JQOBalance, AnalyticalClass 121 CFR 862.2050
JQPCalculator/Data Processing Module, For Clinical UseClass 121 CFR 862.210078
JQQDialyzerClass 121 CFR 862.20501
JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) ClClass 121 CFR 862.240018
JQWStation, Pipetting And Diluting, For Clinical UseClass 121 CFR 862.2750140
JQXNephelometer, For Clinical UseClass 121 CFR 862.270014
JQYPh MeterClass 121 CFR 862.20508
JQZPolarimeterClass 121 CFR 862.20501
JRAMicrotitrator, For Clinical UseClass 121 CFR 862.26801
JRBMicro MixerClass 121 CFR 862.2050
JRCMicro PipetteClass 121 CFR 862.20506
JRERefractometer For Clinical UseClass 121 CFR 862.280013
JRGBlock, HeatingClass 121 CFR 862.20503
JRICuvette, ThermostatedClass 121 CFR 862.20504
JRJUnit, DryingClass 121 CFR 862.20501
JRKEvaporatorClass 121 CFR 862.2050
JRLUnit, Filter, MembraneClass 121 CFR 862.20509
JRMFreezerClass 121 CFR 862.20507
JROBlender/MixerClass 121 CFR 862.2050
JRQShaker/StirrerClass 121 CFR 862.20508
JRRRegulator, TemperatureClass 121 CFR 862.20504
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse OsClass 121 CFR 862.2050
JSQChromatography For Bacterial IdentificationClass 121 CFR 862.22503
JXQMonitor, U.V., GlcClass 121 CFR 862.2250
JXRAtomic Absorption Spectrophotometer, General UseClass 121 CFR 862.285029
KEAResins, Ion-ExchangeClass 121 CFR 862.22309
KHMNephelometric, AmylaseClass 221 CFR 862.10706
KHOFluorometer, For Clinical UseClass 121 CFR 862.256038
KHPAcid, Lactic, Enzymatic MethodClass 121 CFR 862.145027
KHQRadioassay, Triiodothyronine UptakeClass 221 CFR 862.171593
KHSEnzymatic, Carbon-DioxideClass 221 CFR 862.116086
KIEApparatus, High Pressure Liquid ChromatographyClass 121 CFR 862.226025
KLIEnzyme Immunoassay, Non-Radiolabeled, Total ThyroxineClass 221 CFR 862.170086
KLJNad Reduction (U.V.), Phosphohexose IsomeraseClass 121 CFR 862.15701
KMSPhenolphthalein Colorimetry, Carbon-DioxideClass 221 CFR 862.11605
KNKAcid, Uric, Uricase (Colorimetric)Class 121 CFR 862.1775118
KQNRadioassay, Angiotensin Converting EnzymeClass 221 CFR 862.10908
KQOAutomated Urinalysis SystemClass 121 CFR 862.290046
KQPFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl TransferaseClass 221 CFR 862.13157
KWWRadioimmunoassay, Cholyglycine, Bile AcidsClass 221 CFR 862.11776
KWXRadioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile AcidsClass 221 CFR 862.11872
KZQChromatography(Gas), Clinical UseClass 121 CFR 862.225012
KZRChromatography (Liquid, Gel), Clinical UseClass 121 CFR 862.226015
KZSChromatography (Thin Layer), Clinical UseClass 121 CFR 862.2270
LBRLdl & Vldl Precipitation, HdlClass 121 CFR 862.147566
LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, HdlClass 121 CFR 862.147580
LBTElectrophoresis, Cholesterol Via Esterase-Oxidase, HdlClass 121 CFR 862.14758
LCHTonometer (Calibration And Q.C. Of Blood-Gas Instruments), ClinicalClass 121 CFR 862.16609
LCIAutomated Radioimmunoassay Systems, For Clinical UseClass 121 CFR 862.20503
LCXKit, Test, Pregnancy, Hcg, Over The CounterClass 221 CFR 862.1155226
LDMInstrumentation, High Pressure Liquid ChromatographyClass 121 CFR 862.226019
LEQDetectors, Electrochemical, Liquid ChromatographyClass 121 CFR 862.22604